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FDA is announcing the availability of a Guidance on “Contract Manufacturing Arrangements for Drugs: Quality Agreements”

US Food and Drug Administration (FDA) finalized a Guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements’ in November 2016. This guidance is limited to commercial manufacturing activities and describes the definition, establishment and documentation of manufacturing activities of the parties involved in contract drug manufacturing subject to CGMP requirements. Owners and contract facilities can have guidance on quality management principles to carry out the complicated process of contract and to ensure the quality, safety and effectiveness of drugs. In May 2013, draft guidance was published in the Federal register, which has been now replaced with the finalized guidance. With a careful review and consideration of comments received on draft guidance, changes are made to have clarity particularly on the scope and applicability of the guidance and key terms used in the guidance. This guidance is been issued consistent with FDA’s good guidance practices regulation, 21 CFR 10.115.


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